Biased lead connector for operating room cable assembly and methods of making and using

ABSTRACT

An operating room cable assembly for an electrical stimulation system that includes a lead connector having a housing, a lead lumen extending inwardly from a first opening in the housing and configured and arranged to receive a portion of a lead or lead extension, and a contact assembly disposed within the housing and configured and arranged to move relative to the housing. The contact assembly is configured and arranged to move to a load position and is biased to return to a lock position. The contact assembly includes of contacts that are configured and arranged to engage a portion of any lead or lead extension within the lead lumen when the contact assembly is in the lock position and to disengage from the portion of the lead or lead extension within the lead lumen when the contact assembly is in the load position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application Ser. No. 62/559,195, filed Sep. 15, 2017,which is incorporated herein by reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to a biased lead connector for anoperating room cable assembly for use with an implantable electricalstimulation system, as well as methods of making and using the operatingroom cable assembly.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients. Stimulation of the brain,such as deep brain stimulation, can be used to treat a variety ofdiseases or disorders.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

One embodiment is an operating room cable assembly for an electricalstimulation system that includes a lead connector having a housing, alead lumen extending inwardly from a first opening in the housing andconfigured and arranged to receive a portion of a lead or leadextension, and a contact assembly disposed within the housing andconfigured and arranged to move relative to the housing. The contactassembly is configured and arranged to move to a load position and isbiased to return to a lock position. The contact assembly includes ofcontacts that are configured and arranged to engage a portion of anylead or lead extension within the lead lumen when the contact assemblyis in the lock position and to disengage from the portion of the lead orlead extension within the lead lumen when the contact assembly is in theload position.

In at least some embodiments, the operating room cable assembly furtherincludes a button coupled to the contact assembly, disposed within thehousing, and movable relative to the housing, wherein the button isconfigured and arranged to move the contact assembly to the loadposition when the button is pushed and to return the contact assembly tothe lock position when the button is released. In at least someembodiments, the button includes a carriage and the contact assembly isfastened to the carriage. In at least some embodiments, the carriageincludes a lead engagement portion that is configured and arranged toengage the portion of the lead or lead extension in the lead lumen whenthe contact assembly is in the lock position to facilitate retention ofthe lead or lead extension.

In at least some embodiments, the operating room cable assembly furtherincludes an elongated body coupled to, and extending from, the leadconnector and including conductors with each of the conductors coupledto at least one of the contacts of the contact assembly of the leadconnector. In at least some embodiments, the operating room cableassembly further includes a trial stimulator connector coupled to theelongated body and including at least one contact coupled to theconductors of the elongated body.

In at least some embodiments, the operating room cable assembly furtherincludes at least one spring disposed between the contact assembly andthe housing and configured and arranged to bias the contact assembly tothe lock position. In at least some embodiments, the operating roomcable assembly further includes a lead lumen housing disposed within thehousing and defining at least a portion of the lead lumen. In at leastsome embodiments, the lead lumen housing further defines a plurality ofcontact openings that intersect the lead lumen and through which thecontacts of the contact assembly can move between the load position andthe lock position.

In at least some embodiments, the operating room cable assembly furtherincludes a stylet lumen inwardly extending from a second opening in thehousing opposite the lead lumen and intersecting the lead lumen. In atleast some embodiments, the operating room cable assembly furtherincludes a visually distinctive marking disposed on the housing aroundthe first opening. In at least some embodiments, the contacts are “M”shaped pins. In at least some embodiments, the contact assembly includesa base with the contacts attached to the base. In at least someembodiments, the button includes a carriage and the base is part of thecarriage.

Another embodiment is a trial stimulation system that includes a trialstimulator; and any of the operating room cable assemblies describedabove and coupleable, or coupled, to the trial stimulator. The trialstimulation system optionally includes a lead coupleable to the leadconnector of the operating room cable assembly. The trial stimulationsystem optionally includes a lead extension coupleable to the lead andthe lead connector of the operating room cable assembly.

A further embodiment is an insertion kit that includes any of theoperating room cable assemblies described above and at least oneelectrical stimulation lead, each electrical stimulation lead having adistal end portion and a proximal end portion and including electrodesdisposed along the distal end portion of the electrical stimulationlead, terminals disposed along the proximal end portion of theelectrical stimulation lead, and conductors coupling the electrodes tothe terminals, where the proximal end portion of the electricalstimulation lead is insertable into the lead connector of the operatingroom cable assembly.

Yet another embodiment is a method for performing a trial stimulation ona patient. The method includes providing any of the operating room cableassemblies described above; advancing a distal end portion of anelectrical stimulation lead into the patient with a proximal end portionof the electrical stimulation lead extending outward from the patient,wherein the distal end portion of the electrical stimulation lead isadvanced to a position where a plurality of electrodes disposed alongthe distal end portion of the electrical stimulation lead are inproximity to a target stimulation location; placing the proximal endportion of the electrical stimulation lead into the lead connector ofthe operating room cable assembly while the contact assembly is in theload position; and allowing the contact assembly to return to the lockposition to lock the proximal end portion of the lead in the leadconnector.

Another embodiment is a method for performing a trial stimulation on apatient. The method includes providing any of the operating room cableassemblies described above; advancing a distal end portion of anelectrical stimulation lead into the patient with a proximal end portionof the electrical stimulation lead extending outward from the patient,wherein the distal end portion of the electrical stimulation lead isadvanced to a position where a plurality of electrodes disposed alongthe distal end portion of the electrical stimulation lead are inproximity to a target stimulation location; coupling the lead to a leadextension; placing a proximal end portion of the lead extension into thelead connector of the operating room cable assembly while the contactassembly is in the load position; and allowing the contact assembly toreturn to the lock position to lock the proximal end portion of the leadextension in the lead connector.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system that includes a paddle lead electrically coupled to acontrol module, according to the invention;

FIG. 2 is a schematic view of one embodiment of an electricalstimulation system that includes a percutaneous lead electricallycoupled to a control module, according to the invention;

FIG. 3A is a schematic view of one embodiment of the control module ofFIG. 1 configured and arranged to electrically couple to an elongateddevice, according to the invention;

FIG. 3B is a schematic view of one embodiment of a lead extensionconfigured and arranged to electrically couple the elongated device ofFIG. 2 to the control module of FIG. 1, according to the invention;

FIG. 4 is a schematic illustration of components of one embodiment of atrial stimulation system, according to the invention;

FIG. 5A is a schematic perspective view of one embodiment of anoperating room cable assembly, according to the invention;

FIG. 5B is a schematic perspective view of a lead connector of theoperating room cable assembly of FIG. 5A, according to the invention;

FIG. 5C is a schematic side view of the lead connector of the operatingroom cable assembly of FIG. 5A, according to the invention;

FIG. 6A is a schematic exploded view of the lead connector of theoperating room cable assembly of FIG. 5A, according to the invention;

FIG. 6B is a schematic cross-sectional view of the lead connector of theoperating room cable assembly of FIG. 5A, according to the invention;

FIG. 6C is a schematic cut-away view of portions of the button,carriage, and contact assembly of the lead connector of the operatingroom cable assembly of FIG. 5A, according to the invention; and

FIG. 7 is a schematic overview of one embodiment of components of astimulation system, including an electronic subassembly disposed withina control module, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to a push-button lead connector foran operating room cable assembly for use with an implantable electricalstimulation system, as well as methods of making and using the operatingroom cable assembly.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed alonga distal end of the lead and one or more terminals disposed along theone or more proximal ends of the lead. Leads include, for example,percutaneous leads, paddle leads, and cuff leads. Examples of electricalstimulation systems with leads are found in, for example, U.S. Pat. Nos.6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395;7,244,150; 7,672,734; 7,761,165; 7,974,706; 8,175,710; 8,224,450; and8,364,278; and U.S. Patent Application Publication No. 2007/0150036, allof which are incorporated by reference.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102 and a lead103 coupleable to the control module 102. The lead 103 includes a paddlebody 104 and one or more lead bodies 106. In FIG. 1, the lead 103 isshown having two lead bodies 106. It will be understood that the lead103 can include any suitable number of lead bodies including, forexample, one, two, three, four, five, six, seven, eight or more leadbodies 106. An array 133 of electrodes, such as electrode 134, isdisposed on the paddle body 104, and an array of terminals (e.g., 310 inFIG. 3A-3B) is disposed along each of the one or more lead bodies 106.

It will be understood that the electrical stimulation system can includemore, fewer, or different components and can have a variety of differentconfigurations including those configurations disclosed in theelectrical stimulation system references cited herein. For example,instead of a paddle body, the electrodes can be disposed in an array ator near the distal end of a lead body forming a percutaneous lead.

FIG. 2 illustrates schematically another embodiment of the electricalstimulation system 100, where the lead 103 is a percutaneous lead. InFIG. 2, the electrodes 134 are shown disposed along the one or more leadbodies 106. In at least some embodiments, the lead 103 is isodiametricalong a longitudinal length of the lead body 106.

The lead 103 can be coupled to the control module 102 in any suitablemanner. In FIG. 1, the lead 103 is shown coupling directly to thecontrol module 102. In at least some other embodiments, the lead 103couples to the control module 102 via one or more intermediate devices(324 in FIG. 3B). For example, in at least some embodiments one or morelead extensions 324 (see e.g., FIG. 3B) can be disposed between the lead103 and the control module 102 to extend the distance between the lead103 and the control module 102. Other intermediate devices may be usedin addition to, or in lieu of, one or more lead extensions including,for example, a splitter, an adaptor, or the like or combinationsthereof. It will be understood that, in the case where the electricalstimulation system 100 includes multiple elongated devices disposedbetween the lead 103 and the control module 102, the intermediatedevices may be configured into any suitable arrangement.

In FIG. 2, the electrical stimulation system 100 is shown having asplitter 107 configured and arranged for facilitating coupling of thelead 103 to the control module 102. The splitter 107 includes a splitterconnector 108 configured to couple to a proximal end of the lead 103,and one or more splitter tails 109 a and 109 b configured and arrangedto couple to the control module 102 (or another splitter, a leadextension, an adaptor, or the like).

With reference to FIGS. 1 and 2, the control module 102 typicallyincludes a connector housing 112 and a sealed electronics housing 114.An electronic subassembly 110 and an optional power source 120 aredisposed in the electronics housing 114. A control module connector 144is disposed in the connector housing 112. The control module connector144 is configured and arranged to make an electrical connection betweenthe lead 103 and the electronic subassembly 110 of the control module102.

The electrical stimulation system or components of the electricalstimulation system, including the paddle body 104, the one or more ofthe lead bodies 106, and the control module 102, are typically implantedinto the body of a patient. The electrical stimulation system can beused for a variety of applications including, but not limited to deepbrain stimulation, neural stimulation, spinal cord stimulation, musclestimulation, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 134 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, or titanium.

Any suitable number of electrodes 134 can be disposed on the leadincluding, for example, four, five, six, seven, eight, nine, ten,eleven, twelve, fourteen, sixteen, twenty-four, thirty-two, or moreelectrodes 134. In the case of paddle leads, the electrodes 134 can bedisposed on the paddle body 104 in any suitable arrangement. In FIG. 1,the electrodes 134 are arranged into two columns, where each column haseight electrodes 134.

The electrodes of the paddle body 104 (or one or more lead bodies 106)are typically disposed in, or separated by, a non-conductive,biocompatible material such as, for example, silicone, polyurethane,polyetheretherketone (“PEEK”), epoxy, and the like or combinationsthereof. The one or more lead bodies 106 and, if applicable, the paddlebody 104 may be formed in the desired shape by any process including,for example, molding (including injection molding), casting, and thelike. The non-conductive material typically extends from the distal endsof the one or more lead bodies 106 to the proximal end of each of theone or more lead bodies 106.

In the case of paddle leads, the non-conductive material typicallyextends from the paddle body 104 to the proximal end of each of the oneor more lead bodies 106. Additionally, the non-conductive, biocompatiblematerial of the paddle body 104 and the one or more lead bodies 106 maybe the same or different. Moreover, the paddle body 104 and the one ormore lead bodies 106 may be a unitary structure or can be formed as twoseparate structures that are permanently or detachably coupled together.

Terminals (e.g., 310 in FIGS. 3A-3B) are typically disposed along theproximal end of the one or more lead bodies 106 of the electricalstimulation system 100 (as well as any splitters, lead extensions,adaptors, or the like) for electrical connection to correspondingconnector contacts (e.g., 314 in FIG. 3A). The connector contacts aredisposed in connectors (e.g., 144 in FIGS. 1-3B; and 322 FIG. 3B) which,in turn, are disposed on, for example, the control module 102 (or a leadextension, a splitter, an adaptor, or the like). Electrically conductivewires, cables, or the like (not shown) extend from the terminals to theelectrodes 134. Typically, one or more electrodes 134 are electricallycoupled to each terminal. In at least some embodiments, each terminal isonly connected to one electrode 134.

The electrically conductive wires (“conductors”) may be embedded in thenon-conductive material of the lead body 106 or can be disposed in oneor more lumens (not shown) extending along the lead body 106. In someembodiments, there is an individual lumen for each conductor. In otherembodiments, two or more conductors extend through a lumen. There mayalso be one or more lumens (not shown) that open at, or near, theproximal end of the one or more lead bodies 106, for example, forinserting a stylet to facilitate placement of the one or more leadbodies 106 within a body of a patient. Additionally, there may be one ormore lumens (not shown) that open at, or near, the distal end of the oneor more lead bodies 106, for example, for infusion of drugs ormedication into the site of implantation of the one or more lead bodies106. In at least one embodiment, the one or more lumens are flushedcontinually, or on a regular basis, with saline, epidural fluid, or thelike. In at least some embodiments, the one or more lumens arepermanently or removably sealable at the distal end.

FIG. 3A is a schematic side view of one embodiment of a proximal end ofone or more elongated devices 300 configured and arranged for couplingto one embodiment of the control module connector 144. The one or moreelongated devices may include, for example, one or more of the leadbodies 106 of FIG. 1, one or more intermediate devices (e.g., asplitter, the lead extension 324 of FIG. 3B, an adaptor, or the like orcombinations thereof), or a combination thereof.

The control module connector 144 defines at least one port into which aproximal end of the elongated device 300 can be inserted, as shown bydirectional arrows 312 a and 312 b. In FIG. 3A (and in other figures),the connector housing 112 is shown having two ports 304 a and 304 b. Theconnector housing 112 can define any suitable number of ports including,for example, one, two, three, four, five, six, seven, eight, or moreports.

The control module connector 144 also includes a plurality of connectorcontacts, such as connector contact 314, disposed within each port 304 aand 304 b. When the elongated device 300 is inserted into the ports 304a and 304 b, the connector contacts 314 can be aligned with a pluralityof terminals 310 disposed along the proximal end(s) of the elongateddevice(s) 300 to electrically couple the control module 102 to theelectrodes (134 of FIG. 1) disposed on the paddle body 104 of the lead103. Examples of connectors in control modules are found in, forexample, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporatedby reference.

FIG. 3B is a schematic side view of another embodiment of the electricalstimulation system 100. The electrical stimulation system 100 includes alead extension 324 that is configured and arranged to couple one or moreelongated devices 300 (e.g., one of the lead bodies 106 of FIGS. 1 and2, the splitter 107 of FIG. 2, an adaptor, another lead extension, orthe like or combinations thereof) to the control module 102. In FIG. 3B,the lead extension 324 is shown coupled to a single port 304 defined inthe control module connector 144. Additionally, the lead extension 324is shown configured and arranged to couple to a single elongated device300. In alternate embodiments, the lead extension 324 is configured andarranged to couple to multiple ports 304 defined in the control moduleconnector 144, or to receive multiple elongated devices 300, or both.

A lead extension connector 322 is disposed on the lead extension 324. InFIG. 3B, the lead extension connector 322 is shown disposed at a distalend 326 of the lead extension 324. The lead extension connector 322includes a connector housing 328. The connector housing 328 defines atleast one port 330 into which terminals 310 of the elongated device 300can be inserted, as shown by directional arrow 338. The connectorhousing 328 also includes a plurality of connector contacts, such asconnector contacts 340. When the elongated device 300 is inserted intothe port 330, the connector contacts 340 disposed in the connectorhousing 328 can be aligned with the terminals 310 of the elongateddevice 300 to electrically couple the lead extension 324 to theelectrodes (134 of FIGS. 1 and 2) disposed along the lead (103 in FIGS.1 and 2).

In at least some embodiments, the proximal end of the lead extension 324is similarly configured and arranged as a proximal end of the lead 103(or other elongated device 300). The lead extension 324 may include aplurality of electrically conductive wires (not shown) that electricallycouple the connector contacts 340 to a proximal end 348 of the leadextension 324 that is opposite to the distal end 326. In at least someembodiments, the conductive wires disposed in the lead extension 324 canbe electrically coupled to a plurality of terminals (not shown) disposedalong the proximal end 348 of the lead extension 324. In at least someembodiments, the proximal end 348 of the lead extension 324 isconfigured and arranged for insertion into a connector disposed inanother lead extension (or another intermediate device). In otherembodiments (and as shown in FIG. 3B), the proximal end 348 of the leadextension 324 is configured and arranged for insertion into the controlmodule connector 144.

Turning to FIG. 4, during implantation of the lead into a patient it issometimes desirable to test the positioning or functionality of theelectrodes within the patient prior to completion of the implantation.One way to test electrode positioning or functionality is to implant anelectrode-including distal end portion of a lead (and, optionally, oneor more lead extensions) into the patient. The proximal end portion ofthe lead (or lead extension) can then be electrically coupled to a trialstimulator that is disposed external to the patient to perform trialstimulations using the electrodes. Once it is determined that theelectrodes are properly positioned and functioning within desiredparameters, the trial stimulator can be decoupled from the proximal endportion of the lead (or lead extension) and replaced with an implantablecontrol module, and the implantation can be completed.

In some embodiments, the trial stimulations can continue for two, four,six, eight, twelve, or more hours or for one, two, three, four, five ormore days. In these instances, the patient may be in a hospital or othercare facility. In some embodiments, the trial stimulations may continuefor an extended period (e.g., 2-10 days or more) where the patient issent home with the lead, cable, and trial stimulator to assess theeffectiveness of the therapy to determine if a permanent implantedsystem will be effective in treating the medical condition. During thetrial stimulations, the lead can be electrically coupled to the trialstimulator by electrically coupling the proximal end portion of the lead(or lead extension) to an operating room cable (“cable”) which, in turn,is electrically coupled to the trial stimulator. In some cases, whenmultiple leads are implanted into a patient, multiple leads (or leadextensions) may be coupled to the cable.

FIG. 4 is a schematic view of one embodiment of a trial stimulationarrangement 400 that includes a lead 403, a trial stimulator 448, and anoperating room cable assembly 450, that couples the lead 403 to thetrial stimulator 448. The lead 403 includes an array of electrodes 434and an array of terminals 410. The terminals 410 are configured andarranged to couple the electrodes 434 to the trial stimulator 448 whenthe operating room cable assembly 450 is coupled to each of the lead 403and the trial stimulator 448.

During operation, the electrodes 434 are disposed internal to thepatient, while the terminals 410 remain external to the patient, asshown in FIG. 4 by a line 462 schematically representing patient skin.Optionally, the trial stimulation arrangement 400 includes one or moreadditional devices (e.g., a lead extension, an operating room cableextension, a splitter, an adaptor, or the like or any combinationthereof). For example, the trial stimulation arrangement can include alead extension which is coupleable to, and between, the lead 403 and theoperating room cable assembly 450.

The operating room cable assembly 450 includes an elongated body 458having a first end portion 454 and an opposing second end portion 456, alead connector 452 with connector contacts, and an optional trialstimulator connector 460 optionally with terminals (a trial stimulatorconnector and terminals are not needed if the operating room cableassembly is permanently wired, or otherwise permanently attached, to thetrial stimulator). Conductors (not shown) extend from the connectorcontacts of the lead connector to the terminals of the trial stimulatorconnector. The lead connector 452 is disposed along the first endportion 454 of the operating room cable assembly 450 and the connectorcontacts within the lead connector are coupleable to the terminals 434of the lead 403 (or lead extension). The trial stimulator connector 460is disposed along the second end portion 456 of the operating room cableassembly 450 and is coupleable to the trial stimulator 448, eitherdirectly or via one or more operating room cable extensions. Anysuitable terminals can be used in the operating room cable assemblyincluding rings, c-shaped contacts, plate contacts, pogo pins, and thelike. Examples of terminals can be found in, for example, U.S. Pat. Nos.7,539,542 and 8,849,396; U.S. Patent Application Publication No.2013/0098678; and U.S. patent application Ser. No. 14/330,330, all ofwhich are incorporated herein by reference.

Conventionally, the lead connectors of the operating room cable assemblyare relatively large, bulky, and heavy. In some instances, conventionallead connectors may require two hands to operate. In some instances, itmay not be clear to surgical personnel how to load a lead into the leadconnector or how to “lock” the lead within the lead connector.

In the description below, leads will be referred to in connection withthe lead connector. It will be understood, however, that a leadextension can be used in place of any of the leads for coupling to thelead connector with a lead coupled, in turn, to the lead extension.

A lead connector for use with an operating room cable assembly (or as alead connector on a lead extension) can include a simpler, quicker, andeasier locking-unlocking mechanism. One embodiment of an operating roomcable assembly 550 with an elongated body 558, a lead connector 552, andtrial stimulator connector 560 is illustrated in FIG. 5A. Any suitabletrial stimulator connector 560 and elongated body 558 can be usedincluding, but not limited to, those used for conventional or existingoperating room cable assemblies. For example, the elongated body mayinclude multiple conductors extending within a non-conductive sheath orjacket. The trial stimulator connector can be any standard ornon-standard connector with multiple contacts for connecting to a trialstimulator. Alternatively, the operating room cable assembly 560 ispermanently connected to the trial stimulator and does not include atrial stimulator connector.

The lead connector 552, illustrated in close-up views in FIGS. 5B and5C, includes a housing 570 and a button 572 that can be pushed toward acenter of the lead connector to a “load position” (see, FIGS. 5B, 5C,and 6B) for inserting or removing a lead (or lead extension). When thebutton 572 is released, the button is biased to move away from thecenter of the lead connector to a “lock position” to lock the lead inthe lead connector. The housing 570 includes an opening 574 forinsertion of the lead. Optionally, a visually distinctive marking 576can be placed around the opening 574 to facilitate visual identificationof the opening 574 and insertion of the lead. For example, the marking574 can be in a color distinguishable from the surrounding portions ofthe housing 570. The elongated body 558 containing conductors extendsfrom the housing 570 and may include a boot 578 to provide stability orprevent breakage at the exit from the housing and may incorporate astrain relief arrangement.

FIG. 6A illustrates an exploded view of one embodiment of the leadconnector 552; FIG. 6B illustrates a cross-sectional view of thisembodiment in the load position; and FIG. 6C illustrates a cut-away viewof a portion (approximately one half) of selected components of the leadconnector 552. In addition to the housing 570 and the button 572, thelead connector 570 includes a contact assembly 580, a lead lumen housing582, and one or more springs 584. The button, 572, housing 570, and leadlumen housing 582 can be made of any suitable material including, butnot limited to, plastic materials such as silicone, polyurethane, or thelike or combinations thereof. In at least some embodiments, the button,572, housing 570, and lead lumen housing 582 are made solely ofnon-conductive materials. In some embodiments, the housing 570 and leadlumen housing 582 are formed as a single piece and, in otherembodiments, these two components are separate pieces.

The contact assembly 580 includes a base 590 and multiple contacts 592attached to the base. The contact assembly 580 is movable relative tothe housing 570 and can be moved to a load position for receiving thelead. The contact assembly 580 is biased to a lock position in which thecontact assembly the engages a portion of a lead or lead extensionwithin the lead lumen to hold or lock the portion of the lead or leadextension within the lead connector 552.

The base 590 of the contact assembly 580 can be made of any suitablenon-conductive material such as, for example, polyimide, epoxy, otherprinted circuit board materials, flex circuit materials, other plastics,or the like or combinations thereof. The contacts 592 are made of metalor other conductive material and are positioned to engage the terminalsof a lead (or lead extension) when the proximal portion of the lead (orlead extension) is properly and fully inserted in the lead connector 570and the button 572 is in the lock position. As explained further below,the contact assembly 580 is coupled to the button 572 and moves with thebutton 572 to engage the lead (or lead extension) in the lock positionor disengage from the lead (or lead extension) in the load position.Optionally, in the lock position, the contacts 580 may compress orotherwise engage the terminals of the lead to resist removal of theproximal portion of the lead from the lead connector 570.

In the illustrated embodiment, the contacts 592 are “M” shaped pins, butany other suitably shaped contact can be used. Each contact 592 isindividually electrically coupled (for example, directly coupled orcoupled through a wire) to one of multiple conductors 595 (FIG. 6B) thatextend from the lead connector 552 through the elongated body 558 (FIG.5A) and to corresponding contacts of the trial stimulator connector 560(FIG. 5A).

As best illustrated in FIG. 6B, the lead lumen housing 582 and thehousing 572 define a lead lumen 586 that extends into the lead connector552 from the opening 574 and is arranged for receiving a proximal endportion of the lead (or lead extension). Optionally, a stylet opening575 and stylet lumen 587 can also be defined so that a stylet can beinserted through the stylet opening 575 and stylet lumen 587 into theproximal end of the lead (or lead extension). The lead lumen housing 582and housing 572 also define contact openings 596 through which thecontacts 592 can pass as the contacts move from the lock position to theload position and vice versa.

The button 572 includes a carriage 588 to which the contact assembly 580is attached. Any suitable method of attachment can be used including,but not limited to, screws 594, other fasteners, adhesive, or the likeor the carriage 584 and the base 590 of the contact assembly 580 can beformed (e.g., molded) together with, for example, the contacts insertedor otherwise disposed in the combined arrangement. In some embodiments,the button 572 and carriage 588, instead of being a single, integralpiece as illustrated in FIG. 6B, can be made of two or more parts thatare attached together by fasteners, adhesive, or the like.

In at least some embodiments, the springs 584 (FIG. 6A) reside betweenthe carriage 588 and the housing 570 and urge or bias the contactassembly 580 and the button 572 to the lock position. In someembodiments, the housing 570 may include platforms or receptacles forthe springs 584. As the button 572 is pressed to the load position, thecontact assembly 580 moves away from the lead lumen 586. When the button572 is released the springs 584 urge or bias the contact assembly 580and the button 572 to the lock position with the contact assembly 580urged toward the lead lumen 586.

Optionally, the carriage 588 includes a lead engagement portion 589 thatpasses through an opening 577 in the lead lumen housing 582 to engage,or press against, a lead present within the lead lumen 586 to facilitatelocking the lead within the lead lumen. The illustrated embodiment has asingle lead engagement portion 589, but it will be understood thatadditional lead engagement portions can be used and may be part of thecontact assembly 580 instead of the carriage 588.

FIG. 7 is a schematic overview of one embodiment of components of anelectrical stimulation system 700 including an electronic subassembly710 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, a power source 712, an antenna 718,a receiver 702, and a processor 704) of the electrical stimulationsystem can be positioned on one or more circuit boards or similarcarriers within a sealed housing of an implantable pulse generator, ifdesired. Any power source 712 can be used including, for example, abattery such as a primary battery or a rechargeable battery. Examples ofother power sources include super capacitors, nuclear or atomicbatteries, mechanical resonators, infrared collectors, thermally-poweredenergy sources, flexural powered energy sources, bioenergy powersources, fuel cells, bioelectric cells, osmotic pressure pumps, and thelike including the power sources described in U.S. Pat. No. 7,437,193,incorporated herein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 718 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 712 is a rechargeable battery, the battery may berecharged using the optional antenna 718, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 716 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. The processor704 is generally included to control the timing and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 704 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 704 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 704 selectswhich electrode(s) are cathodes and which electrode(s) are anodes. Insome embodiments, the processor 704 is used to identify which electrodesprovide the most useful stimulation of the desired tissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 708 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor704 is coupled to a receiver 702 which, in turn, is coupled to theoptional antenna 718. This allows the processor 704 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 718 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 706 which isprogrammed by the programming unit 708. The programming unit 708 can beexternal to, or part of, the telemetry unit 706. The telemetry unit 706can be a device that is worn on the skin of the user or can be carriedby the user and can have a form similar to a pager, cellular phone, orremote control, if desired. As another alternative, the telemetry unit706 may not be worn or carried by the user but may only be available ata home station or at a clinician's office. The programming unit 708 canbe any unit that can provide information to the telemetry unit 706 fortransmission to the electrical stimulation system 700. The programmingunit 708 can be part of the telemetry unit 706 or can provide signals orinformation to the telemetry unit 706 via a wireless or wiredconnection. One example of a suitable programming unit is a computeroperated by the user or clinician to send signals to the telemetry unit706.

The signals sent to the processor 704 via the antenna 718 and thereceiver 702 can be used to modify or otherwise direct the operation ofthe electrical stimulation system. For example, the signals may be usedto modify the pulses of the electrical stimulation system such asmodifying one or more of pulse duration, pulse frequency, pulsewaveform, and pulse strength. The signals may also direct the electricalstimulation system 700 to cease operation, to start operation, to startcharging the battery, or to stop charging the battery. In otherembodiments, the stimulation system does not include the antenna 718 orreceiver 702 and the processor 704 operates as programmed.

Optionally, the electrical stimulation system 700 may include atransmitter (not shown) coupled to the processor 704 and the antenna 718for transmitting signals back to the telemetry unit 706 or another unitcapable of receiving the signals. For example, the electricalstimulation system 700 may transmit signals indicating whether theelectrical stimulation system 700 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 704 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification provides a description of the manufacture anduse of the invention. Since many embodiments of the invention can bemade without departing from the spirit and scope of the invention, theinvention also resides in the claims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An operating room cable assembly for anelectrical stimulation system, the operating room cable assemblycomprising: a lead connector comprising a housing, a lead lumenextending inwardly from a first opening in the housing and configuredand arranged to receive a portion of a lead or lead extension, acarriage disposed within the housing, and a contact assembly disposed onthe carriage within the housing and configured and arranged to move withthe carriage relative to the housing, wherein the contact assembly andcarriage are configured and arranged to move to a load position and arebiased to return to a lock position, wherein the contact assemblycomprises at least four independent contacts, wherein the contacts ofthe contact assembly are configured and arranged to engage a portion ofany lead or lead extension within the lead lumen when the contactassembly is in the lock position and to disengage from the portion ofthe lead or lead extension within the lead lumen when the contactassembly is in the load position.
 2. The operating room cable assemblyof claim 1, further comprising a button coupled to the contact assembly,disposed within the housing, and movable relative to the housing,wherein the button is configured and arranged to move the contactassembly to the load position when the button is pushed and to returnthe contact assembly to the lock position when the button is released.3. The operating room cable assembly of claim 1, wherein the contactsare “M” shaped pins.
 4. An operating room cable assembly for anelectrical stimulation system, the operating room cable assemblycomprising: a lead connector comprising a housing, a lead lumenextending inwardly from a first opening in the housing and configuredand arranged to receive a portion of a lead or lead extension, a contactassembly disposed within the housing and configured and arranged to moverelative to the housing, wherein the contact assembly is configured andarranged to move to a load position and is biased to return to a lockposition, wherein the contact assembly comprises a plurality ofcontacts, wherein the contacts of the contact assembly are configuredand arranged to engage a portion of any lead or lead extension withinthe lead lumen when the contact assembly is in the lock position and todisengage from the portion of the lead or lead extension within the leadlumen when the contact assembly is in the load position, and a buttoncoupled to the contact assembly, disposed within the housing, andmovable relative to the housing, wherein the button is configured andarranged to move the contact assembly to the load position when thebutton is pushed and to return the contact assembly to the lock positionwhen the button is released, wherein the button comprises a carriage andthe contact assembly is fastened to the carriage.
 5. The operating roomcable assembly of claim 4, wherein the carriage comprises a leadengagement portion that is configured and arranged to engage the portionof the lead or lead extension in the lead lumen when the contactassembly is in the lock position to facilitate retention of the lead orlead extension.
 6. The operating room cable assembly of claim 4, furthercomprising an elongated body coupled to, and extending from, the leadconnector and comprising a plurality of conductors, wherein each of theconductors is coupled to at least one of the contacts of the contactassembly of the lead connector.
 7. The operating room cable assembly ofclaim 6, further comprising a trial stimulator connector coupled to theelongated body and comprising at least one contact coupled to theconductors of the elongated body.
 8. A trial stimulation system,comprising: a trial stimulator; and the operating room cable assembly ofclaim 6 coupleable, or coupled, to the trial stimulator.
 9. The trialstimulation system of claim 8, wherein the operating room cable assemblyfurther comprises a trial stimulator connector coupled to the elongatedbody and coupleable to the trial stimulator.
 10. The trial stimulationsystem of claim 8, wherein the elongated body of the operating roomcable assembly is permanently attached to the trial stimulator.
 11. Thetrial stimulation system of claim 8, further comprising a leadcoupleable to the lead connector of the operating room cable assembly.12. The trial stimulation system of claim 11, further comprising a leadextension coupleable to the lead and the lead connector of the operatingroom cable assembly.
 13. The operating room cable assembly of claim 4,further comprising at least one spring disposed between the contactassembly and the housing and configured and arranged to bias the contactassembly to the lock position.
 14. The operating room cable assembly ofclaim 4, further comprising a lead lumen housing disposed within thehousing and defining at least a portion of the lead lumen.
 15. Theoperating room cable assembly of claim 14, wherein the lead lumenhousing further defines a plurality of contact openings that intersectthe lead lumen and through which the contacts of the contact assemblycan move between the load position and the lock position.
 16. Theoperating room cable assembly of claim 4, further comprising a styletlumen inwardly extending from a second opening in the housing oppositethe lead lumen and intersecting the lead lumen.
 17. The operating roomcable assembly of claim 4, further comprising a visually distinctivemarking disposed on the housing around the first opening.
 18. Aninsertion kit comprising: the operating room cable assembly of claim 4;and at least one electrical stimulation lead, each electricalstimulation lead having a distal end portion and a proximal end portionand comprising a plurality of electrodes disposed along the distal endportion of the electrical stimulation lead, a plurality of terminalsdisposed along the proximal end portion of the electrical stimulationlead, and a plurality of conductors coupling the electrodes to theterminals, wherein the proximal end portion of the electricalstimulation lead is insertable into the lead connector of the operatingroom cable assembly.
 19. A method for performing a trial stimulation ona patient, the method comprising: providing the operating room cableassembly of claim 4; advancing a distal end portion of an electricalstimulation lead into the patient with a proximal end portion of theelectrical stimulation lead extending outward from the patient, whereinthe distal end portion of the electrical stimulation lead is advanced toa position where a plurality of electrodes disposed along the distal endportion of the electrical stimulation lead are in proximity to a targetstimulation location; placing the proximal end portion of the electricalstimulation lead into the lead connector of the operating room cableassembly while the contact assembly is in the load position; andallowing the contact assembly to return to the lock position to lock theproximal end portion of the lead in the lead connector.
 20. A method forperforming a trial stimulation on a patient, the method comprising:providing the operating room cable assembly of claim 4; advancing adistal end portion of an electrical stimulation lead into the patientwith a proximal end portion of the electrical stimulation lead extendingoutward from the patient, wherein the distal end portion of theelectrical stimulation lead is advanced to a position where a pluralityof electrodes disposed along the distal end portion of the electricalstimulation lead are in proximity to a target stimulation location;coupling the lead to a lead extension; placing a proximal end portion ofthe lead extension into the lead connector of the operating room cableassembly while the contact assembly is in the load position; andallowing the contact assembly to return to the lock position to lock theproximal end portion of the lead extension in the lead connector.